[Federal Register Volume 74, Number 87 (Thursday, May 7, 2009)]
[Notices]
[Pages 21371-21372]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-10555]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-N-0192]


Availability of Information Related to the Sentinel Initiative

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
opening of a docket to receive and to make available to the public 
reports and other relevant information received by FDA related to the 
Sentinel Initiative. The goal of the Sentinel Initiative is to develop 
a system that will ultimately enable FDA to actively monitor the safety 
of marketed regulated products. The information that will be made 
available is being developed primarily, but not exclusively, as a 
result of a series of contracts awarded by FDA to inform the 
development of the system. The information will be made available in 
the docket under the docket number at the top of this notice, as well 
as on FDA's Sentinel Initiative Web page (Sentinel Web page) at http://www.fda.gov/oc/initiatives/advance/sentinel/. FDA welcomes interested 
parties, including individuals, to submit to this docket their views 
and perspectives on the information included in the docket or on any 
other aspect of the Sentinel Initiative.

DATES: Submit written or electronic comments at any time.

ADDRESSES: Submit written comments on the information in this docket to 
the Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. 
Submit electronic comments to http://www.regulations.gov. See the 
SUPPLEMENTARY INFORMATION section for electronic access to the 
information.

FOR FURTHER INFORMATION CONTACT: Melissa Robb, Office of Critical Path 
Programs, Food and Drug Administration, 5600 Fishers Lane, Rockville, 
MD 20857, 301-827-1512.

SUPPLEMENTARY INFORMATION:

I. Background

    An important part of FDA's mission is to protect public health by 
monitoring the safety of marketed regulated products. FDA currently has 
a number of reporting systems in place for learning about and tracking 
reports of adverse events and product problems associated with the use 
of FDA-regulated products. However, most of these systems are passive; 
someone (e.g., a healthcare professional, consumer, pharmaceutical 
company) must first report such an event or problem to FDA. To augment 
this mostly passive approach to monitoring postmarket safety, FDA 
announced in May 2008 the development of a system that would enable FDA 
to capitalize on the capabilities of multiple existing electronic 
health care data systems (e.g. electronic health record systems, 
administrative claims databases, registries) to actively monitor 
regulated product safety.
    As currently envisioned, the system would enable FDA to query large 
participating data sources quickly and securely for relevant product 
safety information. FDA would send questions to participating data 
holders, who in turn would, in accordance with existing privacy and 
security safeguards, evaluate their data and send summary results to 
FDA for agency review. This system, which will be developed and 
implemented in stages, is expected to facilitate the development of 
active surveillance methodologies related to signal detection, signal 
strengthening, and signal validation.
    To be successful, the system will require the participation of many 
stakeholders. Since announcing the Sentinel Initiative, FDA has 
fostered a broad public forum to explore the complexities of creating 
such a system. Numerous meetings have been held with a variety of 
stakeholders. Eight contracts have been awarded to explore a variety of 
topics that will inform the development of the system, and a number of 
pilot projects are under way that will contribute to answering some of 
the many technical and policy challenges that need to be addressed. To 
ensure the broadest possible availability of information related to 
FDA's Sentinel Initiative and to encourage public participation in the 
initiative, FDA is announcing the opening of a docket to receive and 
make available to the public reports and other information received by 
FDA related to the Sentinel Initiative. FDA is making this information 
available in the docket listed at the top of this notice, as well as on 
FDA's Sentinel Web page at http://www.fda.gov/oc/initiatives/advance/sentinel/.
    FDA is interested in receiving input from interested parties, 
including individuals, and encourages those parties to submit to this 
docket relevant views and perspectives on the information included in 
the docket or on any other aspect of the Sentinel Initiative.
    As reports and other relevant information are submitted to the 
agency, FDA will make them available to the public by placing them in 
the docket and posting them on the Sentinel Web page. Those persons 
wishing to provide their views and perspectives are encouraged to send 
their input to the docket for broad public consideration.

II. Documents Being Submitted With This Notice

    FDA is making available with this notice the first of a series of 
documents containing reports and other information related to the 
Sentinel Initiative. This document contains a report from the Group 
Health Cooperative Center for Health Studies as a result of the 
contract awarded on Evaluation of Existing Methods for Safety Signal 
Identification for the Sentinel Initiative.

III. Submission of Input on the Contents of This Docket

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) written or electronic views and perspectives regarding 
this information. Submit a single copy of electronic submissions or two 
paper copies of any mailed submissions, except that individuals may 
submit one paper copy. Submissions are to be identified with the docket 
number found in brackets in the heading of this document. Received 
submissions may be seen in the Division of Dockets Management between 9 
a.m. and 4 p.m., Monday through Friday.

[[Page 21372]]

    Electronic comments or submissions will be accepted by FDA only at 
http://www.regulations.gov.

    Dated: April 30, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-10555 Filed 5-6-09; 8:45 am]
BILLING CODE 4160-01-S